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Efficacy and safety of NT 201 for upper limb spasticity of various etiologies – a randomized parallel‐group study |
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| Authors: | M. Barnes A. Schnitzler L. Medeiros M. Aguilar A. Lehnert‐Batar P. Minnasch |
| Affiliation: | 1. 14 Rake House Farm, North Shields, UK;2. H?pital Raymond Poincaré, Service de Médecine Physique et Réadaptation, Garches, France;3. Centro Hospitalar de Lisboa Central, Unidade de Neurologia e Neurofisiologia, Lisbon, Portugal;4. Hospital Mútua de Terrassa, Terrassa, Spain;5. Merz Pharmaceuticals GmbH, Frankfurt/Main, Germany |
| Abstract: | Barnes M, Schnitzler A, Medeiros L, Aguilar M, Lehnert‐Batar A, Minnasch P. Efficacy and safety of NT 201 for upper limb spasticity of various etiologies – a randomized parallel‐group study. Acta Neurol Scand: 2010: 122: 295–302. © 2010 John Wiley & Sons A/S. Objective – To assess efficacy and safety of two dilutions of botulinum neurotoxin type A NT 201 (Xeomin®) in patients with upper limb spasticity of diverse etiology. Methods – Changes in functional disability and muscle tone from baseline to week 4 after NT 201 treatment. Results – One hundred ninety‐two patients with stroke, brain injury, multiple sclerosis, or cerebral palsy were randomized to either 50 or 20 U/ml NT 201 dilutions. The maximum total NT 201 dose was 495 units. Four weeks post‐injection, a ≥ 1‐point reduction was observed on the Disability Assessment Scale in 57.1%, and on the Ashworth scale in ≥ 62.2% of patients. The 20 U/ml NT 201 dilution was non‐inferior to the 50 U/ml NT 201 dilution. Global improvement was rated high by patients (80.2%) and investigators (89.0%). Conclusions – NT 201 improved functional disability and muscle tone and was well tolerated in patients with upper limb spasticity of diverse etiology in both dilutions. |
| Keywords: | botulinum neurotoxin type A etiology functional disability muscle tone NT 201 upper limb spasticity Xeomin |